“I think it is a very opportune time for the clinical research community to expand the way we think about the value of clinical research,” says Jennifer Byrne, CEO of Greater Gift, an organization that offers a program that can provide one child with a free vaccine each time a volunteer joins a clinical trial. She advocates promoting the concept of clinical trials as another layer of patient care.
Byrne is clear about drawing some boundaries and applying definitions to the discussion. “When we talk about clinical research as a care option, we’re not advocating that clinical research is about treatment, in part because of the placebo effect,” she says. Unless a patient is enrolled in a cancer trial or in a rare disease study, whereby there’s no other option for an individual who is receiving some type of study medication, in the vast majority of clinical trials there’s a placebo component, she explains.
“What we do know is that people going into a clinical trial, generally speaking, are followed much more closely by physician investigators and, generally speaking, because we’re answering scientific and medical questions, the level of diagnostic testing is oftentimes much more extensive than what happens in the real world,” Byrne says.
Related: Advances in Competence and Career Path Standardization Initiatives – Join Byrne, who is also former CEO of PMG Research, at ACRP 2018 for this exciting panel session. Learn about collaborative initiatives to standardize professional competence and career paths in clinical research. Attendees will learn about the Core Competence Framework for Clinical Trial Monitoring and hear a case study on its use in AstraZeneca’s initiative to internalize its monitoring program. Updates on development of the Core Competence Framework for Clinical Research Coordinators will also be shared. View Session Details
As an example, consider a recently diagnosed diabetic patient. “More than likely your doctor has a very prescribed kind of care regimen for you,” Byrne notes. “You’re coming in, you’re getting whatever set of tests. You’re getting diagnosed, a prescription is being provided to you, and, probably in the early days, maybe you’re going to come back a little sooner than later. You’re going to come back, let’s say, in a month, and you’re going to be evaluated on the periphery. If everything appears to be fairly stabilized for you, you—as a newly diagnosed diabetic patient—might not be coming back for six months, or in some cases, for 12 months.”
By contrast, a diabetic patient enrolled in a clinical trial is probably receiving a battery of tests beyond what standard practice would dictate. “You’re going to be followed very, very closely,” Byrne says. “So rather than coming in after one or six months post-diagnosis, you’re probably coming in weekly and then, at some point, maybe you’re coming in monthly and you would continue to be monitored much, much more closely.”
Studies have found that, in some diabetic trials, there was a reduction in cost of care for those people somewhere in the magnitude between 60% and 70%.
Of course, cost savings should not be the most important factor. “It wouldn’t be responsible if we were only focused on reducing cost of care without actually looking at outcomes and, more importantly, the long-term patient experience that comes away from” being part of a clinical trial, Byrne said. “We have [also] seen a significant improvement in outcomes for patients.”
Author: Michael Causey